Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess if Lucentis injection applied into the eye is superior to conventional treatment concerning the prevention of visual loss in patients having clinically significant macular edema secondary to retinal vein occlusion

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pecs
• Collaborator: University of Debrecen
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Macular edema persisting for more than 3 months period despite conventional medication.

• Central retinal vein occlusion is confirmed by slit-lamp biomicroscopy and fluorescein angiography (FLAG).

• Patients randomized into ranibizumab-treated group do not receive macular laser treatment.

• Macular edema is defined by OCT: the thickness of central foveal area calculated by macular map analysis is above 280 μm and/or retinal thickness is above 330 μm at any region of the macula calculated by retinal thickness analysis.

• Baseline visual acuity is less than 64 ETDRS letters (or 0.4 decimal equivalent).

Exclusion Criteria:

• Diabetes mellitus

• Additional vitreoretinal diseases

• History of pars plana vitrectomy

• Previous macular grid laser treatment

• Intravitreal triamcinolone acetonid treatment

• Complicated cataract surgery

• Advanced glaucomatous damage of optic nerve head

• Cataract (except mild, defined as grade 1 nuclear sclerosis and/or grade 1 posterior subcapsular cataract)

• Age-related macular degeneration

• Pregnancy and lactation

• Women in childbearing potential who are not using double safe contraception